CompletedNot Applicable

Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption in GBM Patients

Italy, Spain3 participantsStarted 2021-08-25

Plain-language summary

The purpose of this study is to evaluate the safety of the Exablate Model 4000 Type 2.0 used as a tool to disrupt the BBB in patients with high grade glioma undergoing standard of care therapy.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Patient is eligible for adjuvant TMZ treatment.
✓. Men or women age between 18 and 80 years, inclusive.
✓. Able and willing to give informed consent.
✓. Grade IV glioma (GBM) confirmed Subjects
✓. Karnofsky rating 70-100.
✓. Able to communicate during the Exablate BBBD procedure.
✓. Life expectancy of at least 3 months.

Exclusion criteria

✕. Evidence of acute intracranial hemorrhage.
✕. The subject presents with severe symptoms and signs of increased intracranial pressure
✕. Patients with cerebellar or brainstem tumors.
✕. Patients with positive HIV status
✕. Patients with brain tumors containing 1p/19q chromosomal co-deletion
✕. Patient receiving bevacizumab (Avastin) therapy
✕. Patients undergoing other concurrent therapies
✕. Cardiac disease or unstable hemodynamics

What they're measuring

Device and procedure related adverse events

Timeframe: Throughout the study, approximately 12 months.

Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging

Timeframe: At the time of each ExAblate MRgFUS procedure]

Trial details

NCT IDNCT04998864

SponsorInSightec

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-07-27

View on ClinicalTrials.gov More Glioma, Malignant trials